ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer

Xi'an Jiaotong University

Status and phase: Unknown; Early Phase 1

Conditions: Liver Neoplasms; Metastatic Liver Cancer; Hepatocellular Carcinoma; Liver Cancer

Treatments: Biological: ET140202-T cell; Combination Product: TAE combined with ET140202-T cell; Combination Product: Sorafenib combined with ET140202-T cell

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03965546

2019（ZD13）

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer

Full description

The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AFP-expressing HCC and serum AFP >10 x ULN

• Abandon or failure in first or second line treatment

• Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele

• Child-Pugh score of A or B, ECOG 0-2, Life expectancy > 6 months

• Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.

• Negative serum pregnancy test for women with childbearing potential

• Adequate organ function as defined below:

  1. A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
  2. Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
  3. Ejection Fraction measured by echocardiogram or MUGA >50% (evaluation done within 6 weeks of screening does not need to be repeated)
  4. DLCO or FEV1 >45% predicted
  5. Absolute neutrophil count (ANC) ≥ 1500/mm3 (10^9/L), Platelet count ≥ 50,000/mm3 (10^9/L)
  6. INR ≤1.5 x ULN
  7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

• Patients with decompensated cirrhosis: Child-Pugh Score C
• Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
• Patients with an organ transplantation history
• Patients with dependence on corticosteroids
• Patients with active autoimmune diseases requiring systemic immunosuppressive therapy
• Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery
• Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
• Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.
• Patients with other uncontrolled diseases, such as active infections Acute or chronic active hepatitis B or hepatitis C.
• Women who are pregnant or breast-feed
• HIV-infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

ET140202-T cell combine with Sorafenib

Experimental group

Description:

Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion

Treatment:

Combination Product: Sorafenib combined with ET140202-T cell

ET140202-T cell combine with TAE

Experimental group

Description:

TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion

Treatment:

Combination Product: TAE combined with ET140202-T cell

solo ET140202-T cell

Experimental group

Description:

autologous ET140202-T cell administered by intravenous (IV) infusion

Treatment:

Biological: ET140202-T cell